About the Company: Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines,CHC,CMO, and R&D, Data & Digital functions​. SBO strives to be a strategic and functional partner for tactical deliveries to Medical, Health Economics and Value Assessment (HEVA), and Commercial organizations​ in Sanofi, globally.

About the Role: Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Biostatistician Technical Expert - Clinical Statistics within our Clinical Statistics Team at Hyderabad, you’ll lead/oversee statistical support of a team of senior and principal biostatistician

Key Responsibilities: Support the clinical development plan (CDP), clinical study design (including protocol development and review), the study setup and conduct.Conduct / Oversee the execution of the statistical analyses according to the SAP and ISAP, prepare statistical methods & provide statistical insight into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to ensure the statistical integrity of the content according to internal standards and regulatory guidelines and in compliance with SOPs.Serve as a biostatistical consultant for other members of the department and staff members from other statistics department within the organization. Provide mentoring and coaching advanced statistical methodologies to junior statisticians in Hub.Maintain knowledge and awareness of development in biostatistics and clinical trial methodology and regulatory requirements that impact on analysis.Accountable for all assigned statistical deliverables related to multiple studies or specific domains: statistical sections in protocol including sample size calculation, randomization specifications, and statistical methodology, Estimands etc., SAP, data surveillance, statistical analysis results for CSR and its appendices (TLGs and in-text tables).Propose, prepare and perform exploratory data analyses, ad-hoc analyses as relevant for the study or project objectives. Contribute to define and review the specific deliverables related to Transparency and Disclosure.Coordinate with study programmer the production and Qc of statistical analyses.Contribute to operation process optimization and provide inputs to statistics and quality standards.Represent statistics team to participate in scientific or technology working groups or cross function initiatives.